G-CSF

Gilead Provides Update on Phase 3 TROPiCS-04 Study

Retrieved on: 
Giovedì, Maggio 30, 2024
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Hospitals, Clinical Trials, Patient, Progression-free survival, Survival, TPC, UC, Bladder cancer, G-CSF, Diagnosis, FDA, PFS, Breast cancer, ADC, Ageing, ITT, Death, Metastasis, OS, Physician, MUC, Infection, Pharmaceutical industry

Gilead Sciences, Inc. (Nasdaq: GILD) today announced topline results from the confirmatory Phase 3 TROPiCS-04 study in locally advanced or metastatic urothelial cancer (mUC).

Key Points: 
  • Gilead Sciences, Inc. (Nasdaq: GILD) today announced topline results from the confirmatory Phase 3 TROPiCS-04 study in locally advanced or metastatic urothelial cancer (mUC).
  • The study did not meet the primary endpoint of overall survival (OS) in the intention-to-treat (ITT) population.
  • Gilead is continuing to analyze the data and will discuss the results and next steps with the FDA.
  • Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials, including the TROPiCS-04 study.

X4 Pharmaceuticals to Host Virtual Investor Event on June 27, 2024 to Review New Mavorixafor Clinical Data from Ongoing Phase 2 Trial in Chronic Neutropenia

Retrieved on: 
Mercoledì, Maggio 29, 2024
Birth, Patient, G-CSF, Immune system, Safety, Neutropenia, Infection, Pharmaceutical industry

To register for the event, click here .

Key Points: 
  • To register for the event, click here .
  • The event will focus on new interim results from an ongoing Phase 2 clinical trial exploring the use of mavorixafor as a once-daily oral treatment in patients with chronic neutropenia (CN).
  • The data to be presented will include hematological results from at least 15 study participants treated with either mavorixafor monotherapy or mavorixafor in combination with stable doses of injectable granulocyte colony-stimulating factor (G-CSF).
  • Physician expert commentary on the clinical results and the high unmet need in CN will also be included as part of the event.

X4 Pharmaceuticals Reports First-Quarter 2024 Financial Results and Provides Corporate Updates

Retrieved on: 
Martedì, Maggio 7, 2024
Birth, FDA, Capsule, Myelokathexis, Research and development, Priority review, Safety, WHIM syndrome, Food, Security (finance), Conference call, WHIM, Research, Conference, Wart, Neutrophil, CIS, Patient, Society, EMA, Hypogammaglobulinemia, Infection, G-CSF, Interim, Immune system, Lymphocyte, Clinical trial, ID, European Medicines Agency, Pharmaceutical industry

BOSTON, May 07, 2024 (GLOBE NEWSWIRE) -- X4 Pharmaceuticals (Nasdaq: XFOR), a company driven to improve the lives of people with rare diseases of the immune system, today reported financial results for the first quarter ended March 31, 2024 and highlighted key recent and upcoming expected milestones.

Key Points: 
  • ET
    BOSTON, May 07, 2024 (GLOBE NEWSWIRE) -- X4 Pharmaceuticals (Nasdaq: XFOR), a company driven to improve the lives of people with rare diseases of the immune system, today reported financial results for the first quarter ended March 31, 2024 and highlighted key recent and upcoming expected milestones.
  • “Concurrent with this approval, we received a Rare Pediatric Disease Priority Review Voucher, which we intend to monetize.
  • X4 currently expects to seek approval from the European Medicines Agency (EMA) for mavorixafor in WHIM syndrome in late 2024/early 2025.
  • The live webcast will be accessible through the investor relations section of X4 Pharmaceuticals’ website at www.x4pharma.com.

BioLineRx Announces Poster Presentation on Economic Model Data for APHEXDA® (motixafortide) as part of CD34+ Hematopoietic Stem Cell Mobilization in Patients with Multiple Myeloma at ISPOR 2024

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Lunedì, Maggio 6, 2024
Cancer, International Society, Multiple myeloma, TEL, CD34, Value in Health, Filgrastim, Doctor of Philosophy, ASCT, BioLineRx, Patient, MPH, HSC, Pharmacoeconomics, Professional, G-CSF, Nursing

TEL AVIV, Israel, May 6, 2024 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today announced that new economic model data will be presented on APHEXDA® (motixafortide) for CD34+ hematopoietic stem cell (HSC) mobilization in patients with multiple myeloma at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) – The Professional Society for Health Economics and Outcomes Research – 2024 conference, taking place May 5-8, 2024, in Atlanta, Georgia.

Key Points: 
  • TEL AVIV, Israel, May 6, 2024 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today announced that new economic model data will be presented on APHEXDA® (motixafortide) for CD34+ hematopoietic stem cell (HSC) mobilization in patients with multiple myeloma at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) – The Professional Society for Health Economics and Outcomes Research – 2024 conference, taking place May 5-8, 2024, in Atlanta, Georgia.
  • Autologous stem cell transplantation (ASCT) is part of the standard of care treatment paradigm for multiple myeloma and prolongs survival for patients with this cancer type.1 Historically, depending on induction regimens and mobilization strategies, approximately 50% to 75% of patients required more than one apheresis session to collect a target number of cells.2,3 Uncertainty in stem cell mobilization and the possible need for multiple apheresis sessions may result in psychological and logistical burden on patients, in addition to financial and operational inefficiencies for apheresis centers.
  • The data are expected to be published in Value in Health, Volume 27, Issue 6, S1 (June 2024.)
  • Presenter: Jeffrey R Skaar, PhD, Trinity Life Sciences, New York, NY and Jennifer L Lessor, MPH, BioLineRx USA, Inc., Waltham, MA
    The new economic model data to be presented at ISPOR 2024 builds on the evaluation of APHEXDA for CD34+ HSC mobilization in patients with multiple myeloma in apheresis center operations.

First Skeleton-Wide Study of Blood Cell Formation Yields Surprising Findings

Retrieved on: 
Mercoledì, Marzo 20, 2024
Humerus, Cell, Bone marrow, Infection, Disease, Bleeding, Laser, Mechanics, Anatomy, Mouse, Research, Nature, Experimental Hematology, Doctor of Philosophy, Femur, Human, Sternum, Arteriole, Neutrophil, Blood, G-CSF, Division, Marker beacon, Tibia, Skull, Skeleton, Ageing, Vaccine

CINCINNATI, March 20, 2024 /PRNewswire/ -- Imagine being able to count the different types of blood cells being formed inside the tiny bones of a mouse and pinpointing the strings and clusters of cells within the bone marrow that are responsible for producing specific types of blood cells.

Key Points: 
  • "Meanwhile, efforts to stimulate production of certain blood cell types may be dramatically improved by focusing on specific bone types."
  • The key discoveries reported in the paper include:
    New tools allowing visualization of blood production inside the bone, allowing defining the basic anatomy of blood cell formation.
  • Among several examples: blood loss triggered rapid red blood cell production in the sternum, tibia, vertebrae, and humerus -- but not in the skull.
  • Importantly, the process developed for this study allowed the team to analyze blood cell development in multiple parts of the skeleton.

Biotech/Oncology Stocks Targeting the Pancreatic Cancer Market - A Race Worth Winning

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Mercoledì, Marzo 6, 2024
Radiation, Doctor of Philosophy, Immunotherapy, News, FOLFIRINOX, Growth, CADL, PR, CXCR4, Lead, PRS, Multiple myeloma, Poster, Pancreatic cancer, Gemcitabine, Fast Track, Liver, Incidence, Cancer, City, HSC, Chung, TME, Overalls, FACP, Therapy, Sickle cell disease, Columbia University, MAPK, Immune system, SNF, G-CSF, Woman, AIO, SCD, AACR, PD-1, Conference, TILS, Tumor microenvironment, BioLineRx, Clinical trial, Survival, Oncology, Filgrastim, Collection, American Cancer Society, Caregiver, USD, SWI, MD, Blood, FDA, TSX, Biotechnology, Pancreatic Cancer Action Network, Stem cell, RAS, Valaciclovir, PDAC, Patient, Natalizumab, ONC, PEI, Pharmaceutical industry

Research Nester says , "The global pancreatic cancer market size is slated to expand at ~18% CAGR between 2024 and 2036.

Key Points: 
  • Research Nester says , "The global pancreatic cancer market size is slated to expand at ~18% CAGR between 2024 and 2036.
  • The American Cancer Society's estimates for pancreatic cancer in the United States for 2024 are: "About 66,440 people (34,530 men and 31,910 women) will be diagnosed with pancreatic cancer.
  • Pancreatic cancer accounts for about 3% of all cancers in the US and about 7% of all cancer deaths."
  • Biotech/oncology stocks targeting the growing global pancreatic cancer market have made headlines with recent developments and breakthroughs in treatments.

BioLineRx Strengthens Intellectual Property Estate with Notice of Allowance for U.S. Patent Covering Method of Manufacturing Motixafortide (BL-8040) Suitable for Large Scale Production

Retrieved on: 
Lunedì, Marzo 4, 2024
G-CSF, Orphan drug, AML, TEL, FDA, Patent, Patient, Sickle cell disease, IP, Multiple myeloma, Acute myeloid leukemia, Pancreatic cancer, NCE, Pharmaceutical industry

TEL AVIV, Israel, March 4, 2024 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ/TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today announced that it has received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for a patent, "Process for Manufacturing Peptide," covering a method of manufacturing motixafortide (BL-8040) that is suitable for large scale production.

Key Points: 
  • In addition to a broad range of U.S. and international patents covering various aspects of motixafortide, including composition of matter, methods of synthesis, methods of use and combinations, BioLineRx was granted seven years of Orphan Drug market exclusivity beginning on September 8, 2023, the day APHEXDA® (motixafortide) was approved by the FDA, in combination with G-CSF, for use by multiple myeloma patients undergoing autologous stem cell transplantation.
  • Additionally, motixafortide was granted five years of market exclusivity across all indications as a New Chemical Entity (NCE).
  • The NCE exclusivity also commenced on September 8, 2023.
  • Motixafortide has also been granted Orphan Drug Designation in the U.S. and Europe for the treatment of pancreatic cancer, as well as in the U.S. for the treatment of acute myeloid leukemia (AML).

BioLineRx Announces Acceptance of Two Poster Presentations on APHEXDA® (motixafortide) for CD34+ Hematopoietic Stem Cell (HSC) Mobilization in Patients with Multiple Myeloma at the 2024 Tandem Meetings of ASTCT® and CIBMTR®

Retrieved on: 
Venerdì, Febbraio 16, 2024
G-CSF, PD, CD34, TEL, HSC, Stem cell, Safety, Society, Pharmacokinetics, GENESIS, BioLineRx, Patient, Multiple myeloma, Transplant, Filgrastim, Risk, Dentistry

Phase 1 study results demonstrated an extended PD effect with complete receptor occupancy by motixafortide starting at a concentration of 3nM.

Key Points: 
  • Phase 1 study results demonstrated an extended PD effect with complete receptor occupancy by motixafortide starting at a concentration of 3nM.
  • In the GENESIS trial, post-hoc subgroup analyses based on baseline characteristics and risk factors for impaired HSC mobilization demonstrated a consistent benefit of motixafortide + G-CSF over placebo + G-CSF mobilization for all patients.
  • Poster Presentations at the 2024 Tandem Meetings: Transplantation & Cellular Therapy Meetings of the ASTCT and the CIBMTR.
  • Title: Motixafortide Enables Consistent, Robust Hematopoietic Stem Cell Collection (HSC) across Populations with Increased Impaired HSC Mobilization: A Sub-Group Analysis of the Genesis Study
    Presenter: Zachary D. Crees, MD, Washington University School of Medicine in St. Louis

Comprehensive Review Highlights Importance of Leukine® in Combination with Anti-GD2 Immunotherapy for Treatment of High-Risk Pediatric Neuroblastoma

Retrieved on: 
Mercoledì, Gennaio 17, 2024
Lazarus, Neutrophil, Macrophage, Therapy, Canadian International Council, Hook effect, Hematology, G-CSF, Sant Joan, Safety, Hospital, MHC, FDA, PTX, INT, GM-CSF, ADCC, B cell, Vaccine

LEXINGTON, Mass., Jan. 17, 2024 /PRNewswire/ -- Partner Therapeutics, Inc. (PTx) announced today the publication of a comprehensive review by Mora et al.

Key Points: 
  • LEXINGTON, Mass., Jan. 17, 2024 /PRNewswire/ -- Partner Therapeutics, Inc. (PTx) announced today the publication of a comprehensive review by Mora et al.
  • It also describes why the authors believe it is suboptimal to replace with Leukine with G-CSF in this regimen for mechanistic reasons.
  • Leukine has been studied extensively in combination with dinutuximab and naxitamab leading to improved patient outcomes.
  • As a result, all clinical trials supporting the FDA-approval of dinutuximab and naxitamab included Leukine and both products are labeled for use in combination with GM-CSF.

Human medicines European public assessment report (EPAR): Fulphila, pegfilgrastim, Date of authorisation: 20/11/2018, Revision: 12, Status: Authorised

Retrieved on: 
Martedì, Gennaio 2, 2024
Patient, Medical Subject Headings, Marketing, Febrile neutropenia, Filgrastim, INN, Fever, Risk, Bone marrow, Breast cancer, ATC, G-CSF, Pain, International, European, Language, Incidence, Cancer, Neutrophil, European Medicines Agency, Infection, Syndrome, Select, Safety, Anatomy, Malignancy, IIA, Leukemia, Skin, Acute leukemia, Medical device

Human medicines European public assessment report (EPAR): Fulphila, pegfilgrastim, Date of authorisation: 20/11/2018, Revision: 12, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Fulphila, pegfilgrastim, Date of authorisation: 20/11/2018, Revision: 12, Status: Authorised